Job Description

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.The work schedule for this role is Tuesday - Saturday: 4:00pm - 12:30amWorking at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.Our benefits include:

• 401K matching
• PTO
• Employee discount programs
• Medical, dental and vision insurance
• and much more

Independent scientist who demonstrates innovative technical knowledge and significantly contributes to the overall operations of the lab. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation. Demonstrates strong supervisory skills and contributes to the achievement of company and departmental goals and objectives. Perform and directs assays according to and in compliance with Good Laboratory Practice (GLP), current Good Manufacturing Practice (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Acts as Study Director as required.

• Demonstrates innovative and independent scientific technical expertise and proficiency in scientific theory and rigorous practical application in the completion of laboratory procedures and development of new procedures as it relates to microbiological and analytical methods.
• Effectively communicates and defends science through written and verbal communication
• Provides training on technical expertise and compliance issues relevant to the lab setting
• Conducts and directs microbiological assays and lab procedures according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
• Accurately completes batch records and other required documentation according to and in compliance with GLP, cGMP, CFR and/or PTC guidelines and SOPs
• Prepares protocols, final reports, investigations, and deviations as needed
• Conducts critical review of results and reports data appropriately
• As assigned by Management, supervises personnel and assumes all associated responsibilities
• As assigned by Management, acts as Study Director, Lab Manager, and/or Principal Investigator for specific assays and assumes all associated responsibilities
• Trains new personnel in laboratory procedures
• Effectively interacts with clients
• Maintains a laboratory notebook for Research & Development activities as required; reviews and signs laboratory notebooks
• Follows all general and laboratory SOPs
• Normally receives minimal instructions on routine work and detailed instructions on new assignments.

• 5 + years of relevant experience or equivalent for Bachelorsxe2x80x99, 3+ years for Masterxe2x80x99s or 1+ PhD degree in Biological Sciences or related field or equivalent experience.

Knowledge / Skills / Abilities:

• Strong Technical and Scientific knowledge of microbiological based assays (i.e. Sterility test, bacteriostasis/fungistasis, Bacterial Endotoxin Test, and bioburden testing using the Gram stain.
• Ability to use proficiently advanced laboratory equipment, such as, but not limited to; Bactometers, isolators, BET Kinetic/Chromogenic instruments.
• Effective multi-tasking skills and time management required
• Ability to evaluate technical data and record data accurately and legibly
• Ability to accurately and reproducibly perform complex mathematical and statistical calculations
• Ability to use judgment as dictated by complexity of situations
• Ability to understand and follow verbal and demonstrated instructions
• Ability to clearly express and exchange ideas by means of verbal and written communication
• Ability to work effectively as part of a team and exhibit effective interpersonal skills
• Ability to work under limited supervision and to handle problems of a difficult nature

Our Values:Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

WuXi AppTec